Clinician Reviews

The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 

Olivier Le Moal/Getty Images

The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.

Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.

Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.

In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI. 

Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
 

‘A very big day for cardiology’

“This is a very big day for cardiology,” Dr. Ridker said in an interview.

“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.

Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.

He pointed out that the indication for Lodoco was very broad, simply stating that it can be used in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.

But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.

“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.

Dr. Ridker believes that physicians will need time to feel comfortable with this new approach. 

“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.

Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.

The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.

Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.

More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.

The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 

Olivier Le Moal/Getty Images

The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.

Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.

Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.

In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI. 

Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
 

‘A very big day for cardiology’

“This is a very big day for cardiology,” Dr. Ridker said in an interview.

“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.

Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.

He pointed out that the indication for Lodoco was very broad, simply stating that it can be used in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.

But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.

“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.

Dr. Ridker believes that physicians will need time to feel comfortable with this new approach. 

“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.

Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.

The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.

Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.

More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.

The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 

Olivier Le Moal/Getty Images

The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.

Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.

Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.

In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI. 

Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
 

‘A very big day for cardiology’

“This is a very big day for cardiology,” Dr. Ridker said in an interview.

“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.

Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.

He pointed out that the indication for Lodoco was very broad, simply stating that it can be used in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.

But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.

“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.

Dr. Ridker believes that physicians will need time to feel comfortable with this new approach. 

“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.

Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.

The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.

Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.

More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.

The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.

A version of this article first appeared on Medscape.com.

People with nonalcoholic fatty liver disease (NAFLD) are more likely to develop severe infections requiring hospitalization, according to findings from a large Swedish cohort study.

The increased risk was equal to one extra severe infection in every six patients with NAFLD by 20 years after diagnosis, wrote Fahim Ebrahimi, MD, of the Karolinska Institute in Stockholm, and coauthors.

“Accumulating evidence suggests that NAFLD can affect multiple organ systems, which is not surprising, as the liver has multiple functions – regulating metabolism and being a central organ of the immune system,” Dr. Ebrahimi said in an interview.

The study was published online in Clinical Gastroenterology and Hepatology.

“Up to a fifth of cells in the liver are immune cells that process numerous antigens and pathogens from the gastrointestinal tract,” Dr. Ebrahimi noted. “We were intrigued by experimental studies showing that, in NAFLD, many of these key immune cells become dysfunctional at various levels, which may affect disease progression, but at the same time also increase the susceptibility to viral, bacterial, and fungal infections.”

Patients with NAFLD have metabolic risk factors known to increase infection risk, but a smaller study by a different research group had found that NAFLD could independently predispose patients to bacterial infections.

To further explore a connection between NAFLD and infection risk, the researchers looked at data for 12,133 Swedish adults with simple steatosis, nonfibrotic steatohepatitis, noncirrhotic fibrosis, or cirrhosis caused by NAFLD confirmed by liver biopsies performed between 1969 and 2017.

Each patient was matched to five or more contemporary controls from the general population by age, sex, and region of residence. The authors conducted an additional analysis that also adjusted for education, country of birth, and baseline clinical comorbidities, including diabetes, obesity, dyslipidemia, and hypertension, as well as hospitalization preceding the biopsy and chronic obstructive pulmonary disease.

The primary endpoint was severe infections requiring hospital admission. Secondary endpoints included seven prespecified infection subgroups: sepsis; respiratory tract; most gastrointestinal infections; bacterial peritonitis; urogenital; muscle, skin, and soft tissue; and other infections.
 

Elevated risk at all NAFLD stages

Dr. Ebrahimi and colleagues found that over a median follow-up of 14 years, patients with NAFLD had a higher incidence of severe infections – most often respiratory or urinary tract infections – compared with those without NAFLD (32% vs. 17%, respectively).

Biopsy-confirmed NAFLD was also associated with a 71% higher hazard and a 20-year absolute excess risk of 17.3% for severe infections requiring hospital admission versus comparators. The elevated risk showed up in patients with steatosis and increased with the severity of NAFLD. Simple steatosis saw a 64% higher risk (adjusted hazard ratio, 1.64; 95% confidence interval, 1.55-1.73), whereas patients with cirrhosis saw a more than twofold higher risk, compared with controls (aHR, 2.32; 95% CI, 1.92-2.82).

When Dr. Ebrahimi and colleagues adjusted for parameters of the metabolic syndrome, they found an independent increased risk for severe infection. For patients with NAFLD, the increased risk may come from greater susceptibility to infections in general or to a more severe course of infections.

“Our study clearly demonstrates the complexity and high disease burden associated with NAFLD,” Dr. Ebrahimi said. “We are beginning to understand the different layers involved and will eventually move away from a liver-centric view to a more holistic view of the disease.”

Clinicians caring for patients with NAFLD need to be aware of the increased risk for infection, Dr. Ebrahimi said. They also should assess their patients’ vaccination status, and seek to control modifiable risk factors, such as diabetes.

Nancy Reau, MD, of Rush University, Chicago, described the study’s message as important.

“Patients with NAFLD and advancing liver disease are at risk for severe infections,” Dr. Reau said. “When we consider the fact that patients with advanced liver disease tend to die from infectious complications, awareness leading to early recognition and efficient treatment is imperative.”

The authors acknowledged the following limitations: only severe infections requiring hospitalization could be captured; whether infection led to decompensation or vice versa among patients with cirrhosis could not be determined; and detailed data on smoking, alcohol, vaccinations, body mass, and other potentially relevant measures were not available.

The Swiss National Science Foundation, Syskonen Svensson Foundation, and Bengt Ihre Foundation provided grants to Dr. Ebrahimi or coauthors. One coauthor disclosed previous research funding from Janssen and MSD. Dr. Reau disclosed receiving research support and consulting fees from AbbVie and Gilead, as well as consulting fees from Arbutus, Intercept, and Salix.

A version of this article first appeared on Medscape.com.

People with nonalcoholic fatty liver disease (NAFLD) are more likely to develop severe infections requiring hospitalization, according to findings from a large Swedish cohort study.

The increased risk was equal to one extra severe infection in every six patients with NAFLD by 20 years after diagnosis, wrote Fahim Ebrahimi, MD, of the Karolinska Institute in Stockholm, and coauthors.

“Accumulating evidence suggests that NAFLD can affect multiple organ systems, which is not surprising, as the liver has multiple functions – regulating metabolism and being a central organ of the immune system,” Dr. Ebrahimi said in an interview.

The study was published online in Clinical Gastroenterology and Hepatology.

“Up to a fifth of cells in the liver are immune cells that process numerous antigens and pathogens from the gastrointestinal tract,” Dr. Ebrahimi noted. “We were intrigued by experimental studies showing that, in NAFLD, many of these key immune cells become dysfunctional at various levels, which may affect disease progression, but at the same time also increase the susceptibility to viral, bacterial, and fungal infections.”

Patients with NAFLD have metabolic risk factors known to increase infection risk, but a smaller study by a different research group had found that NAFLD could independently predispose patients to bacterial infections.

To further explore a connection between NAFLD and infection risk, the researchers looked at data for 12,133 Swedish adults with simple steatosis, nonfibrotic steatohepatitis, noncirrhotic fibrosis, or cirrhosis caused by NAFLD confirmed by liver biopsies performed between 1969 and 2017.

Each patient was matched to five or more contemporary controls from the general population by age, sex, and region of residence. The authors conducted an additional analysis that also adjusted for education, country of birth, and baseline clinical comorbidities, including diabetes, obesity, dyslipidemia, and hypertension, as well as hospitalization preceding the biopsy and chronic obstructive pulmonary disease.

The primary endpoint was severe infections requiring hospital admission. Secondary endpoints included seven prespecified infection subgroups: sepsis; respiratory tract; most gastrointestinal infections; bacterial peritonitis; urogenital; muscle, skin, and soft tissue; and other infections.
 

Elevated risk at all NAFLD stages

Dr. Ebrahimi and colleagues found that over a median follow-up of 14 years, patients with NAFLD had a higher incidence of severe infections – most often respiratory or urinary tract infections – compared with those without NAFLD (32% vs. 17%, respectively).

Biopsy-confirmed NAFLD was also associated with a 71% higher hazard and a 20-year absolute excess risk of 17.3% for severe infections requiring hospital admission versus comparators. The elevated risk showed up in patients with steatosis and increased with the severity of NAFLD. Simple steatosis saw a 64% higher risk (adjusted hazard ratio, 1.64; 95% confidence interval, 1.55-1.73), whereas patients with cirrhosis saw a more than twofold higher risk, compared with controls (aHR, 2.32; 95% CI, 1.92-2.82).

When Dr. Ebrahimi and colleagues adjusted for parameters of the metabolic syndrome, they found an independent increased risk for severe infection. For patients with NAFLD, the increased risk may come from greater susceptibility to infections in general or to a more severe course of infections.

“Our study clearly demonstrates the complexity and high disease burden associated with NAFLD,” Dr. Ebrahimi said. “We are beginning to understand the different layers involved and will eventually move away from a liver-centric view to a more holistic view of the disease.”

Clinicians caring for patients with NAFLD need to be aware of the increased risk for infection, Dr. Ebrahimi said. They also should assess their patients’ vaccination status, and seek to control modifiable risk factors, such as diabetes.

Nancy Reau, MD, of Rush University, Chicago, described the study’s message as important.

“Patients with NAFLD and advancing liver disease are at risk for severe infections,” Dr. Reau said. “When we consider the fact that patients with advanced liver disease tend to die from infectious complications, awareness leading to early recognition and efficient treatment is imperative.”

The authors acknowledged the following limitations: only severe infections requiring hospitalization could be captured; whether infection led to decompensation or vice versa among patients with cirrhosis could not be determined; and detailed data on smoking, alcohol, vaccinations, body mass, and other potentially relevant measures were not available.

The Swiss National Science Foundation, Syskonen Svensson Foundation, and Bengt Ihre Foundation provided grants to Dr. Ebrahimi or coauthors. One coauthor disclosed previous research funding from Janssen and MSD. Dr. Reau disclosed receiving research support and consulting fees from AbbVie and Gilead, as well as consulting fees from Arbutus, Intercept, and Salix.

A version of this article first appeared on Medscape.com.

People with nonalcoholic fatty liver disease (NAFLD) are more likely to develop severe infections requiring hospitalization, according to findings from a large Swedish cohort study.

The increased risk was equal to one extra severe infection in every six patients with NAFLD by 20 years after diagnosis, wrote Fahim Ebrahimi, MD, of the Karolinska Institute in Stockholm, and coauthors.

“Accumulating evidence suggests that NAFLD can affect multiple organ systems, which is not surprising, as the liver has multiple functions – regulating metabolism and being a central organ of the immune system,” Dr. Ebrahimi said in an interview.

The study was published online in Clinical Gastroenterology and Hepatology.

“Up to a fifth of cells in the liver are immune cells that process numerous antigens and pathogens from the gastrointestinal tract,” Dr. Ebrahimi noted. “We were intrigued by experimental studies showing that, in NAFLD, many of these key immune cells become dysfunctional at various levels, which may affect disease progression, but at the same time also increase the susceptibility to viral, bacterial, and fungal infections.”

Patients with NAFLD have metabolic risk factors known to increase infection risk, but a smaller study by a different research group had found that NAFLD could independently predispose patients to bacterial infections.

To further explore a connection between NAFLD and infection risk, the researchers looked at data for 12,133 Swedish adults with simple steatosis, nonfibrotic steatohepatitis, noncirrhotic fibrosis, or cirrhosis caused by NAFLD confirmed by liver biopsies performed between 1969 and 2017.

Each patient was matched to five or more contemporary controls from the general population by age, sex, and region of residence. The authors conducted an additional analysis that also adjusted for education, country of birth, and baseline clinical comorbidities, including diabetes, obesity, dyslipidemia, and hypertension, as well as hospitalization preceding the biopsy and chronic obstructive pulmonary disease.

The primary endpoint was severe infections requiring hospital admission. Secondary endpoints included seven prespecified infection subgroups: sepsis; respiratory tract; most gastrointestinal infections; bacterial peritonitis; urogenital; muscle, skin, and soft tissue; and other infections.
 

Elevated risk at all NAFLD stages

Dr. Ebrahimi and colleagues found that over a median follow-up of 14 years, patients with NAFLD had a higher incidence of severe infections – most often respiratory or urinary tract infections – compared with those without NAFLD (32% vs. 17%, respectively).

Biopsy-confirmed NAFLD was also associated with a 71% higher hazard and a 20-year absolute excess risk of 17.3% for severe infections requiring hospital admission versus comparators. The elevated risk showed up in patients with steatosis and increased with the severity of NAFLD. Simple steatosis saw a 64% higher risk (adjusted hazard ratio, 1.64; 95% confidence interval, 1.55-1.73), whereas patients with cirrhosis saw a more than twofold higher risk, compared with controls (aHR, 2.32; 95% CI, 1.92-2.82).

When Dr. Ebrahimi and colleagues adjusted for parameters of the metabolic syndrome, they found an independent increased risk for severe infection. For patients with NAFLD, the increased risk may come from greater susceptibility to infections in general or to a more severe course of infections.

“Our study clearly demonstrates the complexity and high disease burden associated with NAFLD,” Dr. Ebrahimi said. “We are beginning to understand the different layers involved and will eventually move away from a liver-centric view to a more holistic view of the disease.”

Clinicians caring for patients with NAFLD need to be aware of the increased risk for infection, Dr. Ebrahimi said. They also should assess their patients’ vaccination status, and seek to control modifiable risk factors, such as diabetes.

Nancy Reau, MD, of Rush University, Chicago, described the study’s message as important.

“Patients with NAFLD and advancing liver disease are at risk for severe infections,” Dr. Reau said. “When we consider the fact that patients with advanced liver disease tend to die from infectious complications, awareness leading to early recognition and efficient treatment is imperative.”

The authors acknowledged the following limitations: only severe infections requiring hospitalization could be captured; whether infection led to decompensation or vice versa among patients with cirrhosis could not be determined; and detailed data on smoking, alcohol, vaccinations, body mass, and other potentially relevant measures were not available.

The Swiss National Science Foundation, Syskonen Svensson Foundation, and Bengt Ihre Foundation provided grants to Dr. Ebrahimi or coauthors. One coauthor disclosed previous research funding from Janssen and MSD. Dr. Reau disclosed receiving research support and consulting fees from AbbVie and Gilead, as well as consulting fees from Arbutus, Intercept, and Salix.

A version of this article first appeared on Medscape.com.

Older people who take daily low-dose aspirin have at 20% higher risk of developing anemia even without having already had a major bleeding event, according to results from a new randomized controlled trial.

In the study, which was published in Annals of Internal Medicine, investigators analyzed data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial and examined hemoglobin concentrations among 19,114 healthy, community-dwelling older patients.

“We knew from large clinical trials, including our ASPREE trial, that daily low-dose aspirin increased the risk of clinically significant bleeding,” said Zoe McQuilten, MBBS, PhD, a hematologist at Monash University in Australia and the study’s lead author. “From our study, we found that low-dose aspirin also increased the risk of anemia during the trial, and this was most likely due to bleeding that was not clinically apparent.”

Anemia is common among elderly patients. It can cause fatigue, fast or irregular heartbeat, headache, chest pain, and pounding or whooshing sounds in the ear, according to the Cleveland Clinic. It can also worsen conditions such as heart failure, cognitive impairment, and depression in people aged 65 and older.

The U.S. Preventive Services Task Force changed its recommendation on aspirin for the primary prevention of cardiovascular disease in 2022, recommending against initiating low-dose aspirin for adults aged 60 years or older. For adults aged 40-59 who have a 10% or greater 10-year risk for cardiovascular disease, the agency recommends that patients and clinicians make the decision to initiate low-dose aspirin use on a case-by-case basis, as the net benefit is small.

Dr. McQuilten said she spent the last 5 years designing substages of anemia and conditions such as blood cancer. In many cases of anemia, doctors are unable to determine the underlying cause, she said. One study published in the Journal of American Geriatrics Society in 2021 found that in about one-third of anemia cases, the etiology was not clear.

About 50% of people older than 60 who were involved in the latest study took aspirin for prevention from 2011 to 2018. That number likely dropped after changes were made to the guidelines in 2022, according to Dr. McQuilten, but long-term use may have continued among older patients. The researchers also examined ferritin levels, which serve as a proxy for iron levels, at baseline and after 3 years.

The incidence of anemia was 51 events per 1,000 person-years in the aspirin group compared with 43 events per 1,000 person-years in the placebo group, according to the researchers. The estimated probability of experiencing anemia within 5 years was 23.5% (95% confidence interval [CI], 22.4%-24.6%) in the aspirin group and 20.3% (95% CI: 19.3% to 21.4%) in the placebo group. Aspirin therapy resulted in a 20% increase in the risk for anemia (95% CI, 1.12-1.29).

People who took aspirin were more likely to have lower serum levels of ferritin at the 3-year mark than were those who received placebo. The average decrease in ferritin among participants who took aspirin was 11.5% greater (95% CI, 9.3%-13.7%) than among those who took placebo.

Basil Eldadah, MD, PhD, supervisory medical officer at the National Institute on Aging, part of the National Institutes of Health, said the findings should encourage clinicians to pay closer attention to hemoglobin levels and have conversations with patients to discuss their need for taking aspirin.

“If somebody is already taking aspirin for any reason, keep an eye on hemoglobin,” said Dr. Eldadah, who was not involved in the study. “For somebody who’s taking aspirin and who’s older, and it’s not for an indication like cardiovascular disease, consider seriously whether that’s the best treatment option.”

The study did not examine the functional consequences of anemia on participants, which Dr. Eldadah said could be fodder for future research. The researchers said one limitation was that it was not clear whether anemia was sufficient to cause symptoms that affected participants’ quality of life or whether occult bleeding caused the anemia. The researchers also did not document whether patients saw their regular physicians and received treatment for anemia over the course of the trial.

The study was funded through grants from the National Health and Medical Research Council and the Bill and Melinda Gates Foundation. The authors reported receiving consulting fees, honoraria, and stock options, and have participated on data monitoring boards not related to the study for Vifor Pharma, ITL Biomedical, Pfizer, Boehringer Ingelheim, Bayer Healthcare, AbbVie, and Abbott Diagnostics.

A version of this article originally appeared on Medscape.com.

Older people who take daily low-dose aspirin have at 20% higher risk of developing anemia even without having already had a major bleeding event, according to results from a new randomized controlled trial.

In the study, which was published in Annals of Internal Medicine, investigators analyzed data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial and examined hemoglobin concentrations among 19,114 healthy, community-dwelling older patients.

“We knew from large clinical trials, including our ASPREE trial, that daily low-dose aspirin increased the risk of clinically significant bleeding,” said Zoe McQuilten, MBBS, PhD, a hematologist at Monash University in Australia and the study’s lead author. “From our study, we found that low-dose aspirin also increased the risk of anemia during the trial, and this was most likely due to bleeding that was not clinically apparent.”

Anemia is common among elderly patients. It can cause fatigue, fast or irregular heartbeat, headache, chest pain, and pounding or whooshing sounds in the ear, according to the Cleveland Clinic. It can also worsen conditions such as heart failure, cognitive impairment, and depression in people aged 65 and older.

The U.S. Preventive Services Task Force changed its recommendation on aspirin for the primary prevention of cardiovascular disease in 2022, recommending against initiating low-dose aspirin for adults aged 60 years or older. For adults aged 40-59 who have a 10% or greater 10-year risk for cardiovascular disease, the agency recommends that patients and clinicians make the decision to initiate low-dose aspirin use on a case-by-case basis, as the net benefit is small.

Dr. McQuilten said she spent the last 5 years designing substages of anemia and conditions such as blood cancer. In many cases of anemia, doctors are unable to determine the underlying cause, she said. One study published in the Journal of American Geriatrics Society in 2021 found that in about one-third of anemia cases, the etiology was not clear.

About 50% of people older than 60 who were involved in the latest study took aspirin for prevention from 2011 to 2018. That number likely dropped after changes were made to the guidelines in 2022, according to Dr. McQuilten, but long-term use may have continued among older patients. The researchers also examined ferritin levels, which serve as a proxy for iron levels, at baseline and after 3 years.

The incidence of anemia was 51 events per 1,000 person-years in the aspirin group compared with 43 events per 1,000 person-years in the placebo group, according to the researchers. The estimated probability of experiencing anemia within 5 years was 23.5% (95% confidence interval [CI], 22.4%-24.6%) in the aspirin group and 20.3% (95% CI: 19.3% to 21.4%) in the placebo group. Aspirin therapy resulted in a 20% increase in the risk for anemia (95% CI, 1.12-1.29).

People who took aspirin were more likely to have lower serum levels of ferritin at the 3-year mark than were those who received placebo. The average decrease in ferritin among participants who took aspirin was 11.5% greater (95% CI, 9.3%-13.7%) than among those who took placebo.

Basil Eldadah, MD, PhD, supervisory medical officer at the National Institute on Aging, part of the National Institutes of Health, said the findings should encourage clinicians to pay closer attention to hemoglobin levels and have conversations with patients to discuss their need for taking aspirin.

“If somebody is already taking aspirin for any reason, keep an eye on hemoglobin,” said Dr. Eldadah, who was not involved in the study. “For somebody who’s taking aspirin and who’s older, and it’s not for an indication like cardiovascular disease, consider seriously whether that’s the best treatment option.”

The study did not examine the functional consequences of anemia on participants, which Dr. Eldadah said could be fodder for future research. The researchers said one limitation was that it was not clear whether anemia was sufficient to cause symptoms that affected participants’ quality of life or whether occult bleeding caused the anemia. The researchers also did not document whether patients saw their regular physicians and received treatment for anemia over the course of the trial.

The study was funded through grants from the National Health and Medical Research Council and the Bill and Melinda Gates Foundation. The authors reported receiving consulting fees, honoraria, and stock options, and have participated on data monitoring boards not related to the study for Vifor Pharma, ITL Biomedical, Pfizer, Boehringer Ingelheim, Bayer Healthcare, AbbVie, and Abbott Diagnostics.

A version of this article originally appeared on Medscape.com.

Older people who take daily low-dose aspirin have at 20% higher risk of developing anemia even without having already had a major bleeding event, according to results from a new randomized controlled trial.

In the study, which was published in Annals of Internal Medicine, investigators analyzed data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial and examined hemoglobin concentrations among 19,114 healthy, community-dwelling older patients.

“We knew from large clinical trials, including our ASPREE trial, that daily low-dose aspirin increased the risk of clinically significant bleeding,” said Zoe McQuilten, MBBS, PhD, a hematologist at Monash University in Australia and the study’s lead author. “From our study, we found that low-dose aspirin also increased the risk of anemia during the trial, and this was most likely due to bleeding that was not clinically apparent.”

Anemia is common among elderly patients. It can cause fatigue, fast or irregular heartbeat, headache, chest pain, and pounding or whooshing sounds in the ear, according to the Cleveland Clinic. It can also worsen conditions such as heart failure, cognitive impairment, and depression in people aged 65 and older.

The U.S. Preventive Services Task Force changed its recommendation on aspirin for the primary prevention of cardiovascular disease in 2022, recommending against initiating low-dose aspirin for adults aged 60 years or older. For adults aged 40-59 who have a 10% or greater 10-year risk for cardiovascular disease, the agency recommends that patients and clinicians make the decision to initiate low-dose aspirin use on a case-by-case basis, as the net benefit is small.

Dr. McQuilten said she spent the last 5 years designing substages of anemia and conditions such as blood cancer. In many cases of anemia, doctors are unable to determine the underlying cause, she said. One study published in the Journal of American Geriatrics Society in 2021 found that in about one-third of anemia cases, the etiology was not clear.

About 50% of people older than 60 who were involved in the latest study took aspirin for prevention from 2011 to 2018. That number likely dropped after changes were made to the guidelines in 2022, according to Dr. McQuilten, but long-term use may have continued among older patients. The researchers also examined ferritin levels, which serve as a proxy for iron levels, at baseline and after 3 years.

The incidence of anemia was 51 events per 1,000 person-years in the aspirin group compared with 43 events per 1,000 person-years in the placebo group, according to the researchers. The estimated probability of experiencing anemia within 5 years was 23.5% (95% confidence interval [CI], 22.4%-24.6%) in the aspirin group and 20.3% (95% CI: 19.3% to 21.4%) in the placebo group. Aspirin therapy resulted in a 20% increase in the risk for anemia (95% CI, 1.12-1.29).

People who took aspirin were more likely to have lower serum levels of ferritin at the 3-year mark than were those who received placebo. The average decrease in ferritin among participants who took aspirin was 11.5% greater (95% CI, 9.3%-13.7%) than among those who took placebo.

Basil Eldadah, MD, PhD, supervisory medical officer at the National Institute on Aging, part of the National Institutes of Health, said the findings should encourage clinicians to pay closer attention to hemoglobin levels and have conversations with patients to discuss their need for taking aspirin.

“If somebody is already taking aspirin for any reason, keep an eye on hemoglobin,” said Dr. Eldadah, who was not involved in the study. “For somebody who’s taking aspirin and who’s older, and it’s not for an indication like cardiovascular disease, consider seriously whether that’s the best treatment option.”

The study did not examine the functional consequences of anemia on participants, which Dr. Eldadah said could be fodder for future research. The researchers said one limitation was that it was not clear whether anemia was sufficient to cause symptoms that affected participants’ quality of life or whether occult bleeding caused the anemia. The researchers also did not document whether patients saw their regular physicians and received treatment for anemia over the course of the trial.

The study was funded through grants from the National Health and Medical Research Council and the Bill and Melinda Gates Foundation. The authors reported receiving consulting fees, honoraria, and stock options, and have participated on data monitoring boards not related to the study for Vifor Pharma, ITL Biomedical, Pfizer, Boehringer Ingelheim, Bayer Healthcare, AbbVie, and Abbott Diagnostics.

A version of this article originally appeared on Medscape.com.

Semaglutide and related drugs for weight loss have co-opted bariatric medicine in recent months. They have also raised serious questions for hospital-based clinicians who wonder whether the drugs may pose risks to surgery patients undergoing anesthesia.

Holding Ozempic (semaglutide) before elective surgery – and if so, for how long – remains largely a judgment call at this point. Official guidance on best practices has not yet caught up to surging popularity of this and other glucagon-like peptide-1 (GLP-1) agonists for weight loss.

Ozempic is indicated for treating type 2 diabetes but also is prescribed off-label for weight loss. Other GLP-1 agents from Novo Nordisk, Wegovy (semaglutide) and Saxenda (liraglutide) injections, are Food and Drug Administration–approved for weight loss. These medications work by decreasing hunger and lowering how much people eat. Semaglutide also is available as a once-daily tablet for type 2 diabetes (Rybelsus).

The American Society of Anesthesiologists (ASA) has been working on guidance on the drugs. “It’s a really hot issue now. We are getting emails from our members looking for guidance,” ASA president Michael Champeau, MD, said in an interview.

But despite the interest in how the medications might affect surgery patients and interact with anesthesia, relatively little evidence exists in the literature beyond case studies. So the society is not issuing official recommendations at this point.

“We’re going to just be calling it ‘guidance’ for right now because of the paucity of the scientific literature,” said Dr. Champeau, adjunct clinical professor of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. “It’s probably not going to have words like ‘must; it will probably have words like ‘should’ or ‘should consider.’ “

The ASA guidance could be out in written form soon, Dr. Champeau added.

Meanwhile, whether physicians should advise stopping these medications 24 hours, 48 hours, or up to 2 weeks before surgery remains unknown.

In search of some consensus, John Shields, MD, an orthopedic surgeon at Atrium Health Wake Forest Baptist Davie Medical Center in Bermuda Run, N.C., asked colleagues on #MedTwitter: “Anyone have guidelines for ozempic around time of surgery? – holding med? – how long NPO?”

Because a full stomach can interfere with anesthesia, clinicians often advise people to stop eating and drinking 12-24 hours before elective procedures (NPO). In the case of once-weekly GLP-1 injections, which can slow gastric emptying, the optimal timeframe remains an open question. The main concern is aspiration, where a patient actively vomits while under anesthesia or their stomach contents passively come back up.

Dr. Shields’ Twitter post garnered significant reaction and comments. Within 4 days, the post was retweeted 30 times and received 72 replies and comments. Dr. Shields noted the general consensus was to hold semaglutide for 1-2 weeks before a procedure. Other suggestions included recommending a liquid diet only for 24-48 hours before surgery, recommending an NPO protocol 24-36 hours in advance, or adjusting the weekly injection so the last dose is taken 5-6 days before surgery.

Anesthesiologist Cliff Gevirtz, MD, has encountered only a few surgical patients so far taking a GLP-1 for weight loss. “And thankfully no aspiration,” added Dr. Gevirtz, clinical director of office-based ambulatory anesthesia services at Somnia Anesthesia in Harrison, N.Y.

To minimize risk, some physicians will perform an ultrasound scan to assess the contents of the stomach. If surgery is elective in a patient with a full stomach, the procedure can get postponed. Another option is to proceed with the case but treat the patient as anesthesiologists approach an emergency procedure. To be safe, many will treat the case as if the patient has a full stomach.

Dr. Gevirtz said he would treat the patient as a ‘full stomach’ and perform a rapid sequence induction with cricoid pressure. He would then extubate the patient once laryngeal reflexes return.

A rapid-sequence induction involves giving the medicine that makes a patient go to sleep, giving another medicine that paralyzes them quickly, then inserting a breathing tube – all within about 30 seconds. Cricoid pressure involves pushing on the neck during intubation to try to seal off the top of the esophagus and again minimize the chances of food coming back up.

Giving metoclopramide 30 minutes before surgery is another option, Dr. Gevirtz said. Metoclopramide can hasten the emptying of stomach contents. Administration in advance is important because waiting for the drug to work can prolong time in the operating room.

Is holding semaglutide before surgery a relevant clinical question? “Yes, very much so,” said Ronnie Fass, MD, division director of gastroenterology and hepatology and the medical director of the Digestive Health Center at The MetroHealth System in Cleveland.

Dr. Fass recommended different strategies based on the semaglutide indication. Currently, clinicians at MetroHealth instruct patients to discontinue diabetic medications the day of surgery. For those who take semaglutide for diabetes, and because the medication is taken once a week, “there is growing discussion among surgeons that the medication should not be stopped prior to surgery. This is to ensure that patients’ diabetes is well controlled before and during surgery,” Dr. Fass said.

In patients taking semaglutide for weight loss only, “there is no clear answer at this point,” he said.

Dr. Fass said the question is complicated by the fact that the medication is taken once a week. “It brings up important questions about the use of the medication during surgery, which may increase the likelihood of side effects in general and for certain types of surgery. Personally, if a patient is taking [semaglutide] for weight loss only, I would consider stopping the medication before surgery.”

The ASA was able to act quickly because it already had an expert task force review how long people should fast before surgery last year – before the explosion in popularity of the GLP-1 agonists.

Although it is still a work in progress, Dr. Champeau offered “a peek” at the recommendations. “The guidance is going to look at how far in advance the drugs should be stopped, rather than looking at making people fast even longer” before surgery, he said. “There’s just no data on that latter question.”

A version of this article originally appeared on Medscape.com.

Semaglutide and related drugs for weight loss have co-opted bariatric medicine in recent months. They have also raised serious questions for hospital-based clinicians who wonder whether the drugs may pose risks to surgery patients undergoing anesthesia.

Holding Ozempic (semaglutide) before elective surgery – and if so, for how long – remains largely a judgment call at this point. Official guidance on best practices has not yet caught up to surging popularity of this and other glucagon-like peptide-1 (GLP-1) agonists for weight loss.

Ozempic is indicated for treating type 2 diabetes but also is prescribed off-label for weight loss. Other GLP-1 agents from Novo Nordisk, Wegovy (semaglutide) and Saxenda (liraglutide) injections, are Food and Drug Administration–approved for weight loss. These medications work by decreasing hunger and lowering how much people eat. Semaglutide also is available as a once-daily tablet for type 2 diabetes (Rybelsus).

The American Society of Anesthesiologists (ASA) has been working on guidance on the drugs. “It’s a really hot issue now. We are getting emails from our members looking for guidance,” ASA president Michael Champeau, MD, said in an interview.

But despite the interest in how the medications might affect surgery patients and interact with anesthesia, relatively little evidence exists in the literature beyond case studies. So the society is not issuing official recommendations at this point.

“We’re going to just be calling it ‘guidance’ for right now because of the paucity of the scientific literature,” said Dr. Champeau, adjunct clinical professor of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. “It’s probably not going to have words like ‘must; it will probably have words like ‘should’ or ‘should consider.’ “

The ASA guidance could be out in written form soon, Dr. Champeau added.

Meanwhile, whether physicians should advise stopping these medications 24 hours, 48 hours, or up to 2 weeks before surgery remains unknown.

In search of some consensus, John Shields, MD, an orthopedic surgeon at Atrium Health Wake Forest Baptist Davie Medical Center in Bermuda Run, N.C., asked colleagues on #MedTwitter: “Anyone have guidelines for ozempic around time of surgery? – holding med? – how long NPO?”

Because a full stomach can interfere with anesthesia, clinicians often advise people to stop eating and drinking 12-24 hours before elective procedures (NPO). In the case of once-weekly GLP-1 injections, which can slow gastric emptying, the optimal timeframe remains an open question. The main concern is aspiration, where a patient actively vomits while under anesthesia or their stomach contents passively come back up.

Dr. Shields’ Twitter post garnered significant reaction and comments. Within 4 days, the post was retweeted 30 times and received 72 replies and comments. Dr. Shields noted the general consensus was to hold semaglutide for 1-2 weeks before a procedure. Other suggestions included recommending a liquid diet only for 24-48 hours before surgery, recommending an NPO protocol 24-36 hours in advance, or adjusting the weekly injection so the last dose is taken 5-6 days before surgery.

Anesthesiologist Cliff Gevirtz, MD, has encountered only a few surgical patients so far taking a GLP-1 for weight loss. “And thankfully no aspiration,” added Dr. Gevirtz, clinical director of office-based ambulatory anesthesia services at Somnia Anesthesia in Harrison, N.Y.

To minimize risk, some physicians will perform an ultrasound scan to assess the contents of the stomach. If surgery is elective in a patient with a full stomach, the procedure can get postponed. Another option is to proceed with the case but treat the patient as anesthesiologists approach an emergency procedure. To be safe, many will treat the case as if the patient has a full stomach.

Dr. Gevirtz said he would treat the patient as a ‘full stomach’ and perform a rapid sequence induction with cricoid pressure. He would then extubate the patient once laryngeal reflexes return.

A rapid-sequence induction involves giving the medicine that makes a patient go to sleep, giving another medicine that paralyzes them quickly, then inserting a breathing tube – all within about 30 seconds. Cricoid pressure involves pushing on the neck during intubation to try to seal off the top of the esophagus and again minimize the chances of food coming back up.

Giving metoclopramide 30 minutes before surgery is another option, Dr. Gevirtz said. Metoclopramide can hasten the emptying of stomach contents. Administration in advance is important because waiting for the drug to work can prolong time in the operating room.

Is holding semaglutide before surgery a relevant clinical question? “Yes, very much so,” said Ronnie Fass, MD, division director of gastroenterology and hepatology and the medical director of the Digestive Health Center at The MetroHealth System in Cleveland.

Dr. Fass recommended different strategies based on the semaglutide indication. Currently, clinicians at MetroHealth instruct patients to discontinue diabetic medications the day of surgery. For those who take semaglutide for diabetes, and because the medication is taken once a week, “there is growing discussion among surgeons that the medication should not be stopped prior to surgery. This is to ensure that patients’ diabetes is well controlled before and during surgery,” Dr. Fass said.

In patients taking semaglutide for weight loss only, “there is no clear answer at this point,” he said.

Dr. Fass said the question is complicated by the fact that the medication is taken once a week. “It brings up important questions about the use of the medication during surgery, which may increase the likelihood of side effects in general and for certain types of surgery. Personally, if a patient is taking [semaglutide] for weight loss only, I would consider stopping the medication before surgery.”

The ASA was able to act quickly because it already had an expert task force review how long people should fast before surgery last year – before the explosion in popularity of the GLP-1 agonists.

Although it is still a work in progress, Dr. Champeau offered “a peek” at the recommendations. “The guidance is going to look at how far in advance the drugs should be stopped, rather than looking at making people fast even longer” before surgery, he said. “There’s just no data on that latter question.”

A version of this article originally appeared on Medscape.com.

Semaglutide and related drugs for weight loss have co-opted bariatric medicine in recent months. They have also raised serious questions for hospital-based clinicians who wonder whether the drugs may pose risks to surgery patients undergoing anesthesia.

Holding Ozempic (semaglutide) before elective surgery – and if so, for how long – remains largely a judgment call at this point. Official guidance on best practices has not yet caught up to surging popularity of this and other glucagon-like peptide-1 (GLP-1) agonists for weight loss.

Ozempic is indicated for treating type 2 diabetes but also is prescribed off-label for weight loss. Other GLP-1 agents from Novo Nordisk, Wegovy (semaglutide) and Saxenda (liraglutide) injections, are Food and Drug Administration–approved for weight loss. These medications work by decreasing hunger and lowering how much people eat. Semaglutide also is available as a once-daily tablet for type 2 diabetes (Rybelsus).

The American Society of Anesthesiologists (ASA) has been working on guidance on the drugs. “It’s a really hot issue now. We are getting emails from our members looking for guidance,” ASA president Michael Champeau, MD, said in an interview.

But despite the interest in how the medications might affect surgery patients and interact with anesthesia, relatively little evidence exists in the literature beyond case studies. So the society is not issuing official recommendations at this point.

“We’re going to just be calling it ‘guidance’ for right now because of the paucity of the scientific literature,” said Dr. Champeau, adjunct clinical professor of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. “It’s probably not going to have words like ‘must; it will probably have words like ‘should’ or ‘should consider.’ “

The ASA guidance could be out in written form soon, Dr. Champeau added.

Meanwhile, whether physicians should advise stopping these medications 24 hours, 48 hours, or up to 2 weeks before surgery remains unknown.

In search of some consensus, John Shields, MD, an orthopedic surgeon at Atrium Health Wake Forest Baptist Davie Medical Center in Bermuda Run, N.C., asked colleagues on #MedTwitter: “Anyone have guidelines for ozempic around time of surgery? – holding med? – how long NPO?”

Because a full stomach can interfere with anesthesia, clinicians often advise people to stop eating and drinking 12-24 hours before elective procedures (NPO). In the case of once-weekly GLP-1 injections, which can slow gastric emptying, the optimal timeframe remains an open question. The main concern is aspiration, where a patient actively vomits while under anesthesia or their stomach contents passively come back up.

Dr. Shields’ Twitter post garnered significant reaction and comments. Within 4 days, the post was retweeted 30 times and received 72 replies and comments. Dr. Shields noted the general consensus was to hold semaglutide for 1-2 weeks before a procedure. Other suggestions included recommending a liquid diet only for 24-48 hours before surgery, recommending an NPO protocol 24-36 hours in advance, or adjusting the weekly injection so the last dose is taken 5-6 days before surgery.

Anesthesiologist Cliff Gevirtz, MD, has encountered only a few surgical patients so far taking a GLP-1 for weight loss. “And thankfully no aspiration,” added Dr. Gevirtz, clinical director of office-based ambulatory anesthesia services at Somnia Anesthesia in Harrison, N.Y.

To minimize risk, some physicians will perform an ultrasound scan to assess the contents of the stomach. If surgery is elective in a patient with a full stomach, the procedure can get postponed. Another option is to proceed with the case but treat the patient as anesthesiologists approach an emergency procedure. To be safe, many will treat the case as if the patient has a full stomach.

Dr. Gevirtz said he would treat the patient as a ‘full stomach’ and perform a rapid sequence induction with cricoid pressure. He would then extubate the patient once laryngeal reflexes return.

A rapid-sequence induction involves giving the medicine that makes a patient go to sleep, giving another medicine that paralyzes them quickly, then inserting a breathing tube – all within about 30 seconds. Cricoid pressure involves pushing on the neck during intubation to try to seal off the top of the esophagus and again minimize the chances of food coming back up.

Giving metoclopramide 30 minutes before surgery is another option, Dr. Gevirtz said. Metoclopramide can hasten the emptying of stomach contents. Administration in advance is important because waiting for the drug to work can prolong time in the operating room.

Is holding semaglutide before surgery a relevant clinical question? “Yes, very much so,” said Ronnie Fass, MD, division director of gastroenterology and hepatology and the medical director of the Digestive Health Center at The MetroHealth System in Cleveland.

Dr. Fass recommended different strategies based on the semaglutide indication. Currently, clinicians at MetroHealth instruct patients to discontinue diabetic medications the day of surgery. For those who take semaglutide for diabetes, and because the medication is taken once a week, “there is growing discussion among surgeons that the medication should not be stopped prior to surgery. This is to ensure that patients’ diabetes is well controlled before and during surgery,” Dr. Fass said.

In patients taking semaglutide for weight loss only, “there is no clear answer at this point,” he said.

Dr. Fass said the question is complicated by the fact that the medication is taken once a week. “It brings up important questions about the use of the medication during surgery, which may increase the likelihood of side effects in general and for certain types of surgery. Personally, if a patient is taking [semaglutide] for weight loss only, I would consider stopping the medication before surgery.”

The ASA was able to act quickly because it already had an expert task force review how long people should fast before surgery last year – before the explosion in popularity of the GLP-1 agonists.

Although it is still a work in progress, Dr. Champeau offered “a peek” at the recommendations. “The guidance is going to look at how far in advance the drugs should be stopped, rather than looking at making people fast even longer” before surgery, he said. “There’s just no data on that latter question.”

A version of this article originally appeared on Medscape.com.

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

A version of this article originally appeared on Medscape.com.

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

A version of this article originally appeared on Medscape.com.

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

A version of this article originally appeared on Medscape.com.

A new statement from the Endocrine Society on hormones and aging highlights the differences between normal aging and disease, and when treatment is and isn’t appropriate.

The idea of the statement “is to be complete, but also to clarify some misunderstandings. ...We tried to be very clear in the language about what we know, where we can go, where we shouldn’t go, and what we still need to learn,” statement coauthor Cynthia A. Stuenkel, MD, of the University of California, San Diego, said in an interview.

The document is divided into nine parts or axes: growth hormone, adrenal, ovarian, testicular, thyroid, osteoporosis, vitamin D deficiency, type 2 diabetes, and water metabolism. Each section covers natural history and observational data in older individuals, available therapies, clinical trial data on efficacy and safety in older individuals, bulleted “key points,” and research gaps.

“Hormones and Aging: An Endocrine Society Scientific Statement” was presented at the annual meeting of the Endocrine Society and published online in the Journal of Clinical Endocrinology & Metabolism.

During a press briefing, writing group chair Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia, said the goal is to “provide a really concise summary across each of these areas. ... There are multiple hormonal changes that occur with age, so we really couldn’t limit ourselves to just one gland or the few that we commonly think about. We wanted to cover all the axes.”

The statement tackles several controversial areas, including hormone therapy for menopausal symptoms in women and hypogonadal symptoms in men, diabetes treatment goals in older adults, distinguishing between age-associated changes in thyroid function and early hypothyroidism, and vitamin D supplementation in older adults.

“Hormones have these almost mythical qualities to some people. ... ‘If I just had my hormones back the way they were, it would all work out.’ What we want to do is make sure that patients are being treated appropriately and that their symptoms are being heard and managed and ascribed to the appropriate problems and not necessarily to hormonal problems when they are not. ... Part of what we need to do is [provide] the evidence that we have, which includes evidence of when not to prescribe as well as [when] to prescribe,” Dr. Cappola said.
 

Not designed to be read all at once

In the menopause section, for example, one “key point” is that menopausal symptoms are common, vary in degree and bother, and can be effectively treated with a variety of therapies proven effective in randomized clinical trials. Another key point is that menopausal hormone therapy is safest for women who are younger than 60 years and less than 10 years since starting menopause.

“It’s almost 20 years since the original Women’s Health Initiative, and that led to an incredible falloff of prescribing hormone therapy and a falloff in teaching of our students, residents, fellows, and practitioners about [menopausal] hormone therapy. ... Hopefully, by issuing this kind of aging statement it gets people to read, think, and learn more. And, hopefully, we can improve the education of physicians. ... Menopause is a universal experience. Clinicians should know about it,” noted Dr. Stuenkel, who chaired the menopause section writing panel.

In the type 2 diabetes section, in the bullet points it is noted that oral glucose tolerance testing may reveal abnormal glucose status in older adults that are not picked up with hemoglobin A1c or fasting glucose levels and that glycemic targets should be individualized.

Asked to comment on the statement, Michele Bellantoni, MD, said: “This was a huge undertaking because there are so many areas of expertise here. I thought they did a very good job of reviewing the literature and showing each of the different hormonal axes. ... It’s a good go-to review.”  

“I thought it was a very good attempt to catalog and provide opportunities for policy, and particularly at [the National Institutes of Health], as they look at funding to show where are these gaps and to support appropriate research. I think the most important aspect to come of this is identifying research gaps for funding opportunities. I very much support that,” noted Dr. Bellantoni, who is clinical director of the division of geriatric medicine at Johns Hopkins University, Baltimore.

However, she also said that the 40-page document might be a bit much for busy clinicians, despite the bullet points at the end of each section.

“I would love to see an editorial that puts into perspective the take-home messages or a subsequent article that distills this into every day practice of care of older adults, both preventative and treatment care. ... I think that would be so useful.”

During the briefing, Dr. Cappola noted that the document need not be read all at once.

“It ended up being a large document, but you should not be intimidated by it because each section is only about 2,000 words. So, it’s really a kind of one-stop shop to be able to look across all these axes at once. We also wanted people to think about the common themes that occur across all these axes when considering what’s going on right now and for future research,” she said.

Dr. Stuenkel, Dr. Cappola, and Dr. Bellantoni reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new statement from the Endocrine Society on hormones and aging highlights the differences between normal aging and disease, and when treatment is and isn’t appropriate.

The idea of the statement “is to be complete, but also to clarify some misunderstandings. ...We tried to be very clear in the language about what we know, where we can go, where we shouldn’t go, and what we still need to learn,” statement coauthor Cynthia A. Stuenkel, MD, of the University of California, San Diego, said in an interview.

The document is divided into nine parts or axes: growth hormone, adrenal, ovarian, testicular, thyroid, osteoporosis, vitamin D deficiency, type 2 diabetes, and water metabolism. Each section covers natural history and observational data in older individuals, available therapies, clinical trial data on efficacy and safety in older individuals, bulleted “key points,” and research gaps.

“Hormones and Aging: An Endocrine Society Scientific Statement” was presented at the annual meeting of the Endocrine Society and published online in the Journal of Clinical Endocrinology & Metabolism.

During a press briefing, writing group chair Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia, said the goal is to “provide a really concise summary across each of these areas. ... There are multiple hormonal changes that occur with age, so we really couldn’t limit ourselves to just one gland or the few that we commonly think about. We wanted to cover all the axes.”

The statement tackles several controversial areas, including hormone therapy for menopausal symptoms in women and hypogonadal symptoms in men, diabetes treatment goals in older adults, distinguishing between age-associated changes in thyroid function and early hypothyroidism, and vitamin D supplementation in older adults.

“Hormones have these almost mythical qualities to some people. ... ‘If I just had my hormones back the way they were, it would all work out.’ What we want to do is make sure that patients are being treated appropriately and that their symptoms are being heard and managed and ascribed to the appropriate problems and not necessarily to hormonal problems when they are not. ... Part of what we need to do is [provide] the evidence that we have, which includes evidence of when not to prescribe as well as [when] to prescribe,” Dr. Cappola said.
 

Not designed to be read all at once

In the menopause section, for example, one “key point” is that menopausal symptoms are common, vary in degree and bother, and can be effectively treated with a variety of therapies proven effective in randomized clinical trials. Another key point is that menopausal hormone therapy is safest for women who are younger than 60 years and less than 10 years since starting menopause.

“It’s almost 20 years since the original Women’s Health Initiative, and that led to an incredible falloff of prescribing hormone therapy and a falloff in teaching of our students, residents, fellows, and practitioners about [menopausal] hormone therapy. ... Hopefully, by issuing this kind of aging statement it gets people to read, think, and learn more. And, hopefully, we can improve the education of physicians. ... Menopause is a universal experience. Clinicians should know about it,” noted Dr. Stuenkel, who chaired the menopause section writing panel.

In the type 2 diabetes section, in the bullet points it is noted that oral glucose tolerance testing may reveal abnormal glucose status in older adults that are not picked up with hemoglobin A1c or fasting glucose levels and that glycemic targets should be individualized.

Asked to comment on the statement, Michele Bellantoni, MD, said: “This was a huge undertaking because there are so many areas of expertise here. I thought they did a very good job of reviewing the literature and showing each of the different hormonal axes. ... It’s a good go-to review.”  

“I thought it was a very good attempt to catalog and provide opportunities for policy, and particularly at [the National Institutes of Health], as they look at funding to show where are these gaps and to support appropriate research. I think the most important aspect to come of this is identifying research gaps for funding opportunities. I very much support that,” noted Dr. Bellantoni, who is clinical director of the division of geriatric medicine at Johns Hopkins University, Baltimore.

However, she also said that the 40-page document might be a bit much for busy clinicians, despite the bullet points at the end of each section.

“I would love to see an editorial that puts into perspective the take-home messages or a subsequent article that distills this into every day practice of care of older adults, both preventative and treatment care. ... I think that would be so useful.”

During the briefing, Dr. Cappola noted that the document need not be read all at once.

“It ended up being a large document, but you should not be intimidated by it because each section is only about 2,000 words. So, it’s really a kind of one-stop shop to be able to look across all these axes at once. We also wanted people to think about the common themes that occur across all these axes when considering what’s going on right now and for future research,” she said.

Dr. Stuenkel, Dr. Cappola, and Dr. Bellantoni reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new statement from the Endocrine Society on hormones and aging highlights the differences between normal aging and disease, and when treatment is and isn’t appropriate.

The idea of the statement “is to be complete, but also to clarify some misunderstandings. ...We tried to be very clear in the language about what we know, where we can go, where we shouldn’t go, and what we still need to learn,” statement coauthor Cynthia A. Stuenkel, MD, of the University of California, San Diego, said in an interview.

The document is divided into nine parts or axes: growth hormone, adrenal, ovarian, testicular, thyroid, osteoporosis, vitamin D deficiency, type 2 diabetes, and water metabolism. Each section covers natural history and observational data in older individuals, available therapies, clinical trial data on efficacy and safety in older individuals, bulleted “key points,” and research gaps.

“Hormones and Aging: An Endocrine Society Scientific Statement” was presented at the annual meeting of the Endocrine Society and published online in the Journal of Clinical Endocrinology & Metabolism.

During a press briefing, writing group chair Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia, said the goal is to “provide a really concise summary across each of these areas. ... There are multiple hormonal changes that occur with age, so we really couldn’t limit ourselves to just one gland or the few that we commonly think about. We wanted to cover all the axes.”

The statement tackles several controversial areas, including hormone therapy for menopausal symptoms in women and hypogonadal symptoms in men, diabetes treatment goals in older adults, distinguishing between age-associated changes in thyroid function and early hypothyroidism, and vitamin D supplementation in older adults.

“Hormones have these almost mythical qualities to some people. ... ‘If I just had my hormones back the way they were, it would all work out.’ What we want to do is make sure that patients are being treated appropriately and that their symptoms are being heard and managed and ascribed to the appropriate problems and not necessarily to hormonal problems when they are not. ... Part of what we need to do is [provide] the evidence that we have, which includes evidence of when not to prescribe as well as [when] to prescribe,” Dr. Cappola said.
 

Not designed to be read all at once

In the menopause section, for example, one “key point” is that menopausal symptoms are common, vary in degree and bother, and can be effectively treated with a variety of therapies proven effective in randomized clinical trials. Another key point is that menopausal hormone therapy is safest for women who are younger than 60 years and less than 10 years since starting menopause.

“It’s almost 20 years since the original Women’s Health Initiative, and that led to an incredible falloff of prescribing hormone therapy and a falloff in teaching of our students, residents, fellows, and practitioners about [menopausal] hormone therapy. ... Hopefully, by issuing this kind of aging statement it gets people to read, think, and learn more. And, hopefully, we can improve the education of physicians. ... Menopause is a universal experience. Clinicians should know about it,” noted Dr. Stuenkel, who chaired the menopause section writing panel.

In the type 2 diabetes section, in the bullet points it is noted that oral glucose tolerance testing may reveal abnormal glucose status in older adults that are not picked up with hemoglobin A1c or fasting glucose levels and that glycemic targets should be individualized.

Asked to comment on the statement, Michele Bellantoni, MD, said: “This was a huge undertaking because there are so many areas of expertise here. I thought they did a very good job of reviewing the literature and showing each of the different hormonal axes. ... It’s a good go-to review.”  

“I thought it was a very good attempt to catalog and provide opportunities for policy, and particularly at [the National Institutes of Health], as they look at funding to show where are these gaps and to support appropriate research. I think the most important aspect to come of this is identifying research gaps for funding opportunities. I very much support that,” noted Dr. Bellantoni, who is clinical director of the division of geriatric medicine at Johns Hopkins University, Baltimore.

However, she also said that the 40-page document might be a bit much for busy clinicians, despite the bullet points at the end of each section.

“I would love to see an editorial that puts into perspective the take-home messages or a subsequent article that distills this into every day practice of care of older adults, both preventative and treatment care. ... I think that would be so useful.”

During the briefing, Dr. Cappola noted that the document need not be read all at once.

“It ended up being a large document, but you should not be intimidated by it because each section is only about 2,000 words. So, it’s really a kind of one-stop shop to be able to look across all these axes at once. We also wanted people to think about the common themes that occur across all these axes when considering what’s going on right now and for future research,” she said.

Dr. Stuenkel, Dr. Cappola, and Dr. Bellantoni reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Given current driving restrictions after syncope, visits to the emergency department for syncope are not significantly associated with increased risk for a subsequent car crash, data suggest.

In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).

“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.

The findings were published online in the Canadian Journal of Cardiology.
 

Case-crossover study

Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.

Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.

“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”

The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.

For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.

An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).

In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
 

Gaps in data

“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”

Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”

Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.

Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
 

‘A messy situation’

In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.

“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.

The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”

Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.

“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.

The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Given current driving restrictions after syncope, visits to the emergency department for syncope are not significantly associated with increased risk for a subsequent car crash, data suggest.

In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).

“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.

The findings were published online in the Canadian Journal of Cardiology.
 

Case-crossover study

Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.

Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.

“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”

The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.

For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.

An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).

In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
 

Gaps in data

“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”

Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”

Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.

Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
 

‘A messy situation’

In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.

“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.

The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”

Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.

“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.

The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Given current driving restrictions after syncope, visits to the emergency department for syncope are not significantly associated with increased risk for a subsequent car crash, data suggest.

In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).

“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.

The findings were published online in the Canadian Journal of Cardiology.
 

Case-crossover study

Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.

Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.

“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”

The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.

For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.

An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).

In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
 

Gaps in data

“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”

Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”

Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.

Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
 

‘A messy situation’

In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.

“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.

The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”

Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.

“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.

The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – Twice as many U.S. adults have obesity based on assessment of their fat volume by dual-energy X-ray absorptiometry (DEXA) scan compared with measurement of body mass index (BMI), a finding that highlights the shortcomings of BMI and adds to the growing case that BMI alone should not be the default gauge for obesity.

“BMI vastly underestimates true obesity,” Aayush Visaria, MD, said at the annual meeting of the Endocrine Society.

His findings highlight that “BMI should be supplemented with other measures of obesity” for the management of individual patients, with assessments that could include a bioelectrical impedance scale or waist circumference, said Dr. Visaria, a researcher at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Visaria cited a new policy issued by the American Medical Association a couple of days before his presentation, which advises that BMI “be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.”

“We’re at the start of the end of BMI,” Dr. Visaria declared during a press briefing at the meeting.

He said DEXA is not practical or cost-effective for obesity screening in routine practice. Therefore, he predicts that waist circumference, often expressed as waist-to-height ratio, will be measured more often, although he acknowledged that waist measurement can be difficult. However, better physician training on the measure should help it become the norm.

Another useful tool for obesity measurement he foresees quickly becoming widespread is bathroom scales that record both weight and body fat percentage using a small electric current to make a bioelectrical impedance measure of adiposity.

Bioimpedance scales will provide more standardized measurements than waist circumference and “revolutionize how we measure obesity,” Dr. Visaria predicted. They are “very accessible and cheap,” he noted, with many models sold for less than $100.
 

Obesity prevalence of 74%

The study by Dr. Visaria and colleagues used data from 9,784 U.S. adults aged 20-59 years (average age, 39 years) collected in several National Health and Nutrition Examination Surveys during 2011-2018. All these participants underwent DEXA assessment of their total body fat as well as a BMI calculation.

Using standard obesity cutoffs for both BMI and total body fat, Dr. Visaria found that DEXA rated 74% of participants as having obesity based on body fat compared with 36% based on BMI.

Among the 64% of the study group who were not obese by BMI, DEXA scans showed 53% of this subgroup did have obesity based on body fat content. Among those with a normal BMI, 43% had obesity by DEXA result.

Further analysis showed that when Dr. Visaria added waist circumference to BMI to enlarge the diagnostic net for obesity it cut the percentage of adults missed as having obesity by BMI alone nearly in half.

Additional analyses showed that the rate of missed diagnoses of obesity by BMI was most common only among people of Hispanic or Asian ethnicity, with both groups showing a 49% rate of obesity by DEXA among those with normal-range BMIs.

The rate of missed obesity diagnoses was highest among all women, with a 59% prevalence of obesity by DEXA among women with a normal-range BMI.

The study received no commercial funding. Dr. Visaria has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – Twice as many U.S. adults have obesity based on assessment of their fat volume by dual-energy X-ray absorptiometry (DEXA) scan compared with measurement of body mass index (BMI), a finding that highlights the shortcomings of BMI and adds to the growing case that BMI alone should not be the default gauge for obesity.

“BMI vastly underestimates true obesity,” Aayush Visaria, MD, said at the annual meeting of the Endocrine Society.

His findings highlight that “BMI should be supplemented with other measures of obesity” for the management of individual patients, with assessments that could include a bioelectrical impedance scale or waist circumference, said Dr. Visaria, a researcher at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Visaria cited a new policy issued by the American Medical Association a couple of days before his presentation, which advises that BMI “be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.”

“We’re at the start of the end of BMI,” Dr. Visaria declared during a press briefing at the meeting.

He said DEXA is not practical or cost-effective for obesity screening in routine practice. Therefore, he predicts that waist circumference, often expressed as waist-to-height ratio, will be measured more often, although he acknowledged that waist measurement can be difficult. However, better physician training on the measure should help it become the norm.

Another useful tool for obesity measurement he foresees quickly becoming widespread is bathroom scales that record both weight and body fat percentage using a small electric current to make a bioelectrical impedance measure of adiposity.

Bioimpedance scales will provide more standardized measurements than waist circumference and “revolutionize how we measure obesity,” Dr. Visaria predicted. They are “very accessible and cheap,” he noted, with many models sold for less than $100.
 

Obesity prevalence of 74%

The study by Dr. Visaria and colleagues used data from 9,784 U.S. adults aged 20-59 years (average age, 39 years) collected in several National Health and Nutrition Examination Surveys during 2011-2018. All these participants underwent DEXA assessment of their total body fat as well as a BMI calculation.

Using standard obesity cutoffs for both BMI and total body fat, Dr. Visaria found that DEXA rated 74% of participants as having obesity based on body fat compared with 36% based on BMI.

Among the 64% of the study group who were not obese by BMI, DEXA scans showed 53% of this subgroup did have obesity based on body fat content. Among those with a normal BMI, 43% had obesity by DEXA result.

Further analysis showed that when Dr. Visaria added waist circumference to BMI to enlarge the diagnostic net for obesity it cut the percentage of adults missed as having obesity by BMI alone nearly in half.

Additional analyses showed that the rate of missed diagnoses of obesity by BMI was most common only among people of Hispanic or Asian ethnicity, with both groups showing a 49% rate of obesity by DEXA among those with normal-range BMIs.

The rate of missed obesity diagnoses was highest among all women, with a 59% prevalence of obesity by DEXA among women with a normal-range BMI.

The study received no commercial funding. Dr. Visaria has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – Twice as many U.S. adults have obesity based on assessment of their fat volume by dual-energy X-ray absorptiometry (DEXA) scan compared with measurement of body mass index (BMI), a finding that highlights the shortcomings of BMI and adds to the growing case that BMI alone should not be the default gauge for obesity.

“BMI vastly underestimates true obesity,” Aayush Visaria, MD, said at the annual meeting of the Endocrine Society.

His findings highlight that “BMI should be supplemented with other measures of obesity” for the management of individual patients, with assessments that could include a bioelectrical impedance scale or waist circumference, said Dr. Visaria, a researcher at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Visaria cited a new policy issued by the American Medical Association a couple of days before his presentation, which advises that BMI “be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.”

“We’re at the start of the end of BMI,” Dr. Visaria declared during a press briefing at the meeting.

He said DEXA is not practical or cost-effective for obesity screening in routine practice. Therefore, he predicts that waist circumference, often expressed as waist-to-height ratio, will be measured more often, although he acknowledged that waist measurement can be difficult. However, better physician training on the measure should help it become the norm.

Another useful tool for obesity measurement he foresees quickly becoming widespread is bathroom scales that record both weight and body fat percentage using a small electric current to make a bioelectrical impedance measure of adiposity.

Bioimpedance scales will provide more standardized measurements than waist circumference and “revolutionize how we measure obesity,” Dr. Visaria predicted. They are “very accessible and cheap,” he noted, with many models sold for less than $100.
 

Obesity prevalence of 74%

The study by Dr. Visaria and colleagues used data from 9,784 U.S. adults aged 20-59 years (average age, 39 years) collected in several National Health and Nutrition Examination Surveys during 2011-2018. All these participants underwent DEXA assessment of their total body fat as well as a BMI calculation.

Using standard obesity cutoffs for both BMI and total body fat, Dr. Visaria found that DEXA rated 74% of participants as having obesity based on body fat compared with 36% based on BMI.

Among the 64% of the study group who were not obese by BMI, DEXA scans showed 53% of this subgroup did have obesity based on body fat content. Among those with a normal BMI, 43% had obesity by DEXA result.

Further analysis showed that when Dr. Visaria added waist circumference to BMI to enlarge the diagnostic net for obesity it cut the percentage of adults missed as having obesity by BMI alone nearly in half.

Additional analyses showed that the rate of missed diagnoses of obesity by BMI was most common only among people of Hispanic or Asian ethnicity, with both groups showing a 49% rate of obesity by DEXA among those with normal-range BMIs.

The rate of missed obesity diagnoses was highest among all women, with a 59% prevalence of obesity by DEXA among women with a normal-range BMI.

The study received no commercial funding. Dr. Visaria has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Men who illicitly used anabolic-androgenic steroids to bulk up and then turned to illegal, web-based regimens for treating their steroid withdrawal complications have provided important clues for new approaches to treating a growing worldwide population of men who abuse steroids.

A retrospective, observational study at one steroid addiction center in Glasgow examined 641 men who had stopped using steroids within the prior 3 years in 2015-2022 and who had self-administered certain agents, collectively known as post-cycle therapy (PCT) – within 3 months of stopping steroids.

They had a significant 3.8-fold increased rate of normalization of their levels of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), compared with men who either never used PCT or began it more than 3 months after stopping steroids, Channa N. Jayasena, PhD, MRCP, FRCPath, reported at the annual meeting of the Endocrine Society.

These testosterone, LH, and FSH levels served as a “surrogate marker of biochemical recovery from hypogonadism,” he explained. Normalization also occurred “slightly sooner” in men who began using PCT early after steroid cessation, added Dr. Jayasena, a reproductive endocrinologist at Imperial College, London.

When men recovered their endogenous testosterone-producing capacity, it occurred after an average of about 13 weeks on PCT and after an average of about 19 weeks without PCT, a significant difference.

“There is a vacuum of medical advice on what to do” when men stop taking steroids, said Dr. Jayasena during a press briefing at the meeting. “We can’t recommend anything yet because [our studies] have not proven causality” between the post-cycle therapy that many men start after stopping steroids and any symptom improvement they experience.”

The next step is to test the PCT agents in a prospective, controlled study, an investigation Dr. Jayasena and colleagues are eager to launch. The goal is to determine whether PCT is truly effective, the optimal doses, and whether the treatments are safe.
 

‘Incredibly sophisticated’ online community

The agents that constitute PCT include human chorionic gonadotropin (hCG, the “pregnancy hormone”), selective estrogen receptor modulators (SERMs), and aromatase inhibitors (AIs). SERMs and AIs are licensed only for use in women, the former for osteoporosis and breast cancer and the latter for breast cancer.

All of these agents, as well as others, are advertised by various illegal websites as treatments that can restore endogenous testosterone production in men whose native testosterone shut down during their steroid self-medication.

Restored testosterone resolves many of the adverse effects of steroid withdrawal such as diminished libido and erections, and depressed mood and energy.

Men buy PCT agents illegally from various websites. “There is an enormous, incredibly sophisticated community online that influences” PCT, and an “incredibly refined worldwide distribution network,” Dr. Jayasena explained.

His study included 410 men who turned to PCT after steroid cessation and 170 who did not.
 

Largest study of hormone recovery when men stop taking steroids

In a further multivariate analysis of the observational data, men who had used four or more different steroid treatments fared worse – with a significant 75% reduced rate of testosterone normalization with PCT – compared with men who had used a single steroid agent.

And men who had been on a steroid regimen for more than 6 months also fared badly – with a significant 66% reduced rate of testosterone normalization with PCT, compared with men on a steroid regimen for 3 months or less.

“This is the largest study of hormone recovery when men stop taking steroids,” Dr. Jayasena noted.

And the data “require corroboration within an interventional study to determine causality.”

“We need further studies to help doctors and other health care professionals advise men about the risks of anabolic steroid use and support those who are motivated to stop,” Dr. Jayasena said.

He cautioned that the study has several limitations: biases were potentially introduced based on recruitment and on recall by participants; clinicians drew blood specimens used to measure hormone levels at random times; and participants may have engaged in concealed drug use and used steroid and PCT agents that did not contain the substances advertised.

Nevertheless, “Our data provide primary evidence that self-administered PCT drugs may be associated with improved biochemical recovery” from steroid-induced hypogonadism, and they “may have important therapeutic implications for the future treatment of men who are motivated to stop” steroids.

The study received no commercial funding. Dr. Jayasena has received research funding from Logixx Pharma.

A version of this article first appeared on Medscape.com.

Men who illicitly used anabolic-androgenic steroids to bulk up and then turned to illegal, web-based regimens for treating their steroid withdrawal complications have provided important clues for new approaches to treating a growing worldwide population of men who abuse steroids.

A retrospective, observational study at one steroid addiction center in Glasgow examined 641 men who had stopped using steroids within the prior 3 years in 2015-2022 and who had self-administered certain agents, collectively known as post-cycle therapy (PCT) – within 3 months of stopping steroids.

They had a significant 3.8-fold increased rate of normalization of their levels of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), compared with men who either never used PCT or began it more than 3 months after stopping steroids, Channa N. Jayasena, PhD, MRCP, FRCPath, reported at the annual meeting of the Endocrine Society.

These testosterone, LH, and FSH levels served as a “surrogate marker of biochemical recovery from hypogonadism,” he explained. Normalization also occurred “slightly sooner” in men who began using PCT early after steroid cessation, added Dr. Jayasena, a reproductive endocrinologist at Imperial College, London.

When men recovered their endogenous testosterone-producing capacity, it occurred after an average of about 13 weeks on PCT and after an average of about 19 weeks without PCT, a significant difference.

“There is a vacuum of medical advice on what to do” when men stop taking steroids, said Dr. Jayasena during a press briefing at the meeting. “We can’t recommend anything yet because [our studies] have not proven causality” between the post-cycle therapy that many men start after stopping steroids and any symptom improvement they experience.”

The next step is to test the PCT agents in a prospective, controlled study, an investigation Dr. Jayasena and colleagues are eager to launch. The goal is to determine whether PCT is truly effective, the optimal doses, and whether the treatments are safe.
 

‘Incredibly sophisticated’ online community

The agents that constitute PCT include human chorionic gonadotropin (hCG, the “pregnancy hormone”), selective estrogen receptor modulators (SERMs), and aromatase inhibitors (AIs). SERMs and AIs are licensed only for use in women, the former for osteoporosis and breast cancer and the latter for breast cancer.

All of these agents, as well as others, are advertised by various illegal websites as treatments that can restore endogenous testosterone production in men whose native testosterone shut down during their steroid self-medication.

Restored testosterone resolves many of the adverse effects of steroid withdrawal such as diminished libido and erections, and depressed mood and energy.

Men buy PCT agents illegally from various websites. “There is an enormous, incredibly sophisticated community online that influences” PCT, and an “incredibly refined worldwide distribution network,” Dr. Jayasena explained.

His study included 410 men who turned to PCT after steroid cessation and 170 who did not.
 

Largest study of hormone recovery when men stop taking steroids

In a further multivariate analysis of the observational data, men who had used four or more different steroid treatments fared worse – with a significant 75% reduced rate of testosterone normalization with PCT – compared with men who had used a single steroid agent.

And men who had been on a steroid regimen for more than 6 months also fared badly – with a significant 66% reduced rate of testosterone normalization with PCT, compared with men on a steroid regimen for 3 months or less.

“This is the largest study of hormone recovery when men stop taking steroids,” Dr. Jayasena noted.

And the data “require corroboration within an interventional study to determine causality.”

“We need further studies to help doctors and other health care professionals advise men about the risks of anabolic steroid use and support those who are motivated to stop,” Dr. Jayasena said.

He cautioned that the study has several limitations: biases were potentially introduced based on recruitment and on recall by participants; clinicians drew blood specimens used to measure hormone levels at random times; and participants may have engaged in concealed drug use and used steroid and PCT agents that did not contain the substances advertised.

Nevertheless, “Our data provide primary evidence that self-administered PCT drugs may be associated with improved biochemical recovery” from steroid-induced hypogonadism, and they “may have important therapeutic implications for the future treatment of men who are motivated to stop” steroids.

The study received no commercial funding. Dr. Jayasena has received research funding from Logixx Pharma.

A version of this article first appeared on Medscape.com.

Men who illicitly used anabolic-androgenic steroids to bulk up and then turned to illegal, web-based regimens for treating their steroid withdrawal complications have provided important clues for new approaches to treating a growing worldwide population of men who abuse steroids.

A retrospective, observational study at one steroid addiction center in Glasgow examined 641 men who had stopped using steroids within the prior 3 years in 2015-2022 and who had self-administered certain agents, collectively known as post-cycle therapy (PCT) – within 3 months of stopping steroids.

They had a significant 3.8-fold increased rate of normalization of their levels of testosterone, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), compared with men who either never used PCT or began it more than 3 months after stopping steroids, Channa N. Jayasena, PhD, MRCP, FRCPath, reported at the annual meeting of the Endocrine Society.

These testosterone, LH, and FSH levels served as a “surrogate marker of biochemical recovery from hypogonadism,” he explained. Normalization also occurred “slightly sooner” in men who began using PCT early after steroid cessation, added Dr. Jayasena, a reproductive endocrinologist at Imperial College, London.

When men recovered their endogenous testosterone-producing capacity, it occurred after an average of about 13 weeks on PCT and after an average of about 19 weeks without PCT, a significant difference.

“There is a vacuum of medical advice on what to do” when men stop taking steroids, said Dr. Jayasena during a press briefing at the meeting. “We can’t recommend anything yet because [our studies] have not proven causality” between the post-cycle therapy that many men start after stopping steroids and any symptom improvement they experience.”

The next step is to test the PCT agents in a prospective, controlled study, an investigation Dr. Jayasena and colleagues are eager to launch. The goal is to determine whether PCT is truly effective, the optimal doses, and whether the treatments are safe.
 

‘Incredibly sophisticated’ online community

The agents that constitute PCT include human chorionic gonadotropin (hCG, the “pregnancy hormone”), selective estrogen receptor modulators (SERMs), and aromatase inhibitors (AIs). SERMs and AIs are licensed only for use in women, the former for osteoporosis and breast cancer and the latter for breast cancer.

All of these agents, as well as others, are advertised by various illegal websites as treatments that can restore endogenous testosterone production in men whose native testosterone shut down during their steroid self-medication.

Restored testosterone resolves many of the adverse effects of steroid withdrawal such as diminished libido and erections, and depressed mood and energy.

Men buy PCT agents illegally from various websites. “There is an enormous, incredibly sophisticated community online that influences” PCT, and an “incredibly refined worldwide distribution network,” Dr. Jayasena explained.

His study included 410 men who turned to PCT after steroid cessation and 170 who did not.
 

Largest study of hormone recovery when men stop taking steroids

In a further multivariate analysis of the observational data, men who had used four or more different steroid treatments fared worse – with a significant 75% reduced rate of testosterone normalization with PCT – compared with men who had used a single steroid agent.

And men who had been on a steroid regimen for more than 6 months also fared badly – with a significant 66% reduced rate of testosterone normalization with PCT, compared with men on a steroid regimen for 3 months or less.

“This is the largest study of hormone recovery when men stop taking steroids,” Dr. Jayasena noted.

And the data “require corroboration within an interventional study to determine causality.”

“We need further studies to help doctors and other health care professionals advise men about the risks of anabolic steroid use and support those who are motivated to stop,” Dr. Jayasena said.

He cautioned that the study has several limitations: biases were potentially introduced based on recruitment and on recall by participants; clinicians drew blood specimens used to measure hormone levels at random times; and participants may have engaged in concealed drug use and used steroid and PCT agents that did not contain the substances advertised.

Nevertheless, “Our data provide primary evidence that self-administered PCT drugs may be associated with improved biochemical recovery” from steroid-induced hypogonadism, and they “may have important therapeutic implications for the future treatment of men who are motivated to stop” steroids.

The study received no commercial funding. Dr. Jayasena has received research funding from Logixx Pharma.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration draft guidance released recently on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Mont. 

“I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use. 

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing, and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said. 

Commonly reported symptoms of tattoo ink–associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria, which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination, including: 

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Dr. Brod said. 

Between 2003 and 2023, there were 18 recalls of tattoo inks that were contaminated with various microorganisms, according to the FDA. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.

Reputable ink manufacturers use a process called gamma radiation, which refers to electromagnetic radiation of high frequencies to kill microorganisms in the ink and its packaging.

Most of the trustworthy, high-quality ink manufacturers are well-known among tattoo artists, Ms. Donohue said. 

While she has seen customers with sensitive skin have allergic reactions, she has not seen someone come back with an infection in her 9 years working in the tattoo industry.

Because tattoo ink is considered a cosmetic product, there is not much regulatory oversight involved, which means the sterility and quality of ingredients vary, said Teo Soleymani, MD, an assistant clinical professor of dermatology and dermatological surgery at the UCLA David Geffen School of Medicine.

“Cosmeceuticals aren’t regulated by the FDA like prescription medication,” he said. “What we’ve seen many times is inadvertent contamination during the application process or contamination while the inks are being made.”

In years past, unclean needles spreading hepatitis and HIV were more of a concern, but those rates have dropped significantly, Dr. Soleymani said. 

The infections that have increased are from rare bacteria that exist in stagnant water. And they are injected into a part of the body that allows them to evade the immune system, he said: shallow enough that there aren’t many associated blood vessels, but not still below the layer of skin that gets sloughed off every 28 days. 

Sometimes, antibiotics alone won’t cut it, and the tattoo will require surgical removal. 

“The aesthetic you were going for has to be not only removed, but you’re left with a surgical scar,” Dr. Soleymani said. “Tattoos can be beautiful, but they can come with unwanted visitors that can cause months of misery.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration draft guidance released recently on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Mont. 

“I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use. 

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing, and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said. 

Commonly reported symptoms of tattoo ink–associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria, which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination, including: 

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Dr. Brod said. 

Between 2003 and 2023, there were 18 recalls of tattoo inks that were contaminated with various microorganisms, according to the FDA. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.

Reputable ink manufacturers use a process called gamma radiation, which refers to electromagnetic radiation of high frequencies to kill microorganisms in the ink and its packaging.

Most of the trustworthy, high-quality ink manufacturers are well-known among tattoo artists, Ms. Donohue said. 

While she has seen customers with sensitive skin have allergic reactions, she has not seen someone come back with an infection in her 9 years working in the tattoo industry.

Because tattoo ink is considered a cosmetic product, there is not much regulatory oversight involved, which means the sterility and quality of ingredients vary, said Teo Soleymani, MD, an assistant clinical professor of dermatology and dermatological surgery at the UCLA David Geffen School of Medicine.

“Cosmeceuticals aren’t regulated by the FDA like prescription medication,” he said. “What we’ve seen many times is inadvertent contamination during the application process or contamination while the inks are being made.”

In years past, unclean needles spreading hepatitis and HIV were more of a concern, but those rates have dropped significantly, Dr. Soleymani said. 

The infections that have increased are from rare bacteria that exist in stagnant water. And they are injected into a part of the body that allows them to evade the immune system, he said: shallow enough that there aren’t many associated blood vessels, but not still below the layer of skin that gets sloughed off every 28 days. 

Sometimes, antibiotics alone won’t cut it, and the tattoo will require surgical removal. 

“The aesthetic you were going for has to be not only removed, but you’re left with a surgical scar,” Dr. Soleymani said. “Tattoos can be beautiful, but they can come with unwanted visitors that can cause months of misery.”

A version of this article first appeared on WebMD.com.

The Food and Drug Administration draft guidance released recently on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, Mont. 

“I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know if it’s going to be repackaged.”

Tattoo artists themselves, she said, regulate the quality of ink they use. 

Still, the threat is real, said Bruce Brod, MD, a clinical professor of dermatology at the University of Pennsylvania Health System. “I’ve seen several different infections from tattooing, and they are from organisms that tend to contaminate things in damp, liquid-type environments.”

The FDA released the new draft guidance aiming to reduce the use of pathogen-contaminated tattoo ink, which can cause stubborn infections that are especially hard to treat, dermatologists said.

“Tattooing involves puncturing the epidermis about 100 times per second with needles and depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis,” the guidance states. “Contaminated tattoo ink can cause infections and serious injuries. Because these inks are injected, pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

The guidance comes as body art continues to get more popular. According to a 2019 poll, 30% of Americans had at least one tattoo – up from 21% in 2012. Forty percent of people 18-34 and 36% of those ages 35-54 had at least one tattoo. And though they are commonplace, tattoos come with medical risks that should be known beforehand, doctors said. 

Commonly reported symptoms of tattoo ink–associated infections include rashes, blisters, painful nodules, and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is nontuberculous mycobacteria, which is related to the bacteria that causes tuberculosis and can be found in soil and water.

The guidance lists several unsanitary manufacturing conditions that may lead to ink contamination, including: 

• Preparing or packing of tattoo inks in facilities that are hard to sanitize, such as carpeted areas
• Ink or ink components left uncovered, especially near open air ducts
• Unsanitary mixing of tattoo inks, including with unclean utensils or containers
• Lack of appropriate attire by staff, failure to use hairnets, lab coats, aprons, gowns, masks, or gloves

“Infections will often spread along the drainage channels in the skin and create squiggly, uneven lines of big red, lumpy nodules,” Dr. Brod said. 

Between 2003 and 2023, there were 18 recalls of tattoo inks that were contaminated with various microorganisms, according to the FDA. In May 2019, the FDA issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.

Reputable ink manufacturers use a process called gamma radiation, which refers to electromagnetic radiation of high frequencies to kill microorganisms in the ink and its packaging.

Most of the trustworthy, high-quality ink manufacturers are well-known among tattoo artists, Ms. Donohue said. 

While she has seen customers with sensitive skin have allergic reactions, she has not seen someone come back with an infection in her 9 years working in the tattoo industry.

Because tattoo ink is considered a cosmetic product, there is not much regulatory oversight involved, which means the sterility and quality of ingredients vary, said Teo Soleymani, MD, an assistant clinical professor of dermatology and dermatological surgery at the UCLA David Geffen School of Medicine.

“Cosmeceuticals aren’t regulated by the FDA like prescription medication,” he said. “What we’ve seen many times is inadvertent contamination during the application process or contamination while the inks are being made.”

In years past, unclean needles spreading hepatitis and HIV were more of a concern, but those rates have dropped significantly, Dr. Soleymani said. 

The infections that have increased are from rare bacteria that exist in stagnant water. And they are injected into a part of the body that allows them to evade the immune system, he said: shallow enough that there aren’t many associated blood vessels, but not still below the layer of skin that gets sloughed off every 28 days. 

Sometimes, antibiotics alone won’t cut it, and the tattoo will require surgical removal. 

“The aesthetic you were going for has to be not only removed, but you’re left with a surgical scar,” Dr. Soleymani said. “Tattoos can be beautiful, but they can come with unwanted visitors that can cause months of misery.”

A version of this article first appeared on WebMD.com.